BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2664338 · Received July 22, 2012

    Report

    Report Number
    3007566237-2012-01714
    Event Type
    Injury
    Date Received
    July 22, 2012
    Date of Event
    April 3, 2012
    Report Date
    June 28, 2012
    Manufacturer
    NEURO SULLIVAN LAKE
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3873, LOT #: V142491, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: SCREENING.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012 THAT DURING A SURGICAL PROCEDURE TO REPLACE THE PATIENT'S TRIAL LEADS WITH PERMANENT LEADS, THE PHYSICIAN HAD NOTED "WHITE SCARRING" AT THE LEAD TRACK. THE PHYSICIAN CUT DOWN OR STRIPPED THIS VISIBLE SCAR TISSUE BEFORE PLACING THE PERMANENT LEAD. ADDITIONAL INFORMATION REPORTED ON (B)(6) 2012 REPORTED THAT DURING AN INTRA-OPERATIVE IMPEDANCE TEST, ALL ELECTRODES YIELDED VALUES OF AROUND 1000 OHMS. THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION AND NO FURTHER TESTING OR INTERVENTION WAS PLANNED. IT WAS INDICATED THAT THE PHYSICIAN DOES NOT TYPICALLY NOTE VISIBLE SCARRING AROUND THE TRIAL LEAD(S) AREA FOLLOWING THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO SULLIVAN LAKE NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention